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Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate in People With Asthma

20 novembre 2016 mis à jour par: GlaxoSmithKline

A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Multi-centre Study to Evaluate the Efficacy and Safety of Inhaled Fluticasone Furoate in the Treatment of Persistent Asthma in Adults and Adolescents Not Currently Receiving Inhaled Corticosteroids

A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This will be a multi-centre, randomised, placebo controlled (with rescue medication), double-blind, parallel group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period. Subjects failing screening will not be eligible for re-screening. During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom score and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised to either inhaled Fluticasone Furoate 50 mcg or inhaled placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 4 on-treatment visits at Visits 3, 4, 5, and 6 (Weeks 2, 4, 8 and 12 respectively). Subjects will receive treatment for 84 days (12 weeks). A follow-up contact will be performed 1-week after completing study medication (Visit 7). Subjects will participate in the study for up to a maximum of 15 weeks (including screening, treatment and follow-up contact).

Type d'étude

Interventionnel

Inscription (Réel)

248

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Fédération Russe
      • Klin, Fédération Russe, 141600
        • GSK Investigational Site
      • Moscow, Fédération Russe, 115446
        • GSK Investigational Site
      • Saratov, Fédération Russe, 410028
        • GSK Investigational Site
      • St. Petersburg, Fédération Russe, 194356
        • GSK Investigational Site
      • Voronezh, Fédération Russe, 394066
        • GSK Investigational Site
      • Yaroslavl, Fédération Russe, 150003
        • GSK Investigational Site
  • Mexique
    • Jalisco
      • Zapopan, Jalisco, Mexique, 45040
        • GSK Investigational Site
    • Michoacán
      • Morelia, Michoacán, Mexique, 58070
        • GSK Investigational Site
    • Tabasco
      • Villahermosa, Tabasco, Mexique, 86100
        • GSK Investigational Site
  • Pérou
      • Lima, Pérou, Lima 1
        • GSK Investigational Site
      • Lima, Pérou, Lima 27
        • GSK Investigational Site
    • Lima
      • Lima 18, Lima, Pérou
        • GSK Investigational Site
      • San Borja, Lima, Pérou, Lima 41
        • GSK Investigational Site
      • San Miguel, Lima, Pérou, Lima 32
        • GSK Investigational Site
  • États-Unis
    • California
      • Long Beach, California, États-Unis, 90808
        • GSK Investigational Site
      • Los Angeles, California, États-Unis, 90025
        • GSK Investigational Site
      • Newport Beach, California, États-Unis, 92663
        • GSK Investigational Site
    • Georgia
      • Albany, Georgia, États-Unis, 31707
        • GSK Investigational Site
    • Missouri
      • Columbia, Missouri, États-Unis, 65203
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73103
        • GSK Investigational Site
    • South Carolina
      • Orangeburg, South Carolina, États-Unis, 29118
        • GSK Investigational Site
      • Spartanburg, South Carolina, États-Unis, 29303
        • GSK Investigational Site
    • Texas
      • Corsicana, Texas, États-Unis, 75110
        • GSK Investigational Site
      • Waco, Texas, États-Unis, 76712
        • GSK Investigational Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Signed informed consent
  • Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks before first visit
  • Both genders; females of child bearing potential must be willing to use appropriate contraception during the study
  • Pre-bronchodilator FEV1 of at least 60% predicted
  • FEV1 reversibility of at least 12% and 200mls
  • Current asthma therapy that includes a non-corticosteroid controller and/or short-acting beta agonist

Exclusion Criteria:

  • History of life-threatening asthma exacerbation within the past 10 years
  • Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months
  • Current or recent respiratory infection or current oral candida infection
  • Presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome
  • Known or suspected allergy to study drug or materials
  • Taking another investigational medication or prohibited medication during the study
  • Previous treatment with inhaled fluticasone furoate in a phase II or III study
  • Current smokers or former smokers with significant tobacco exposure
  • Children in Care

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Fluticasone furoate 50mcg
Inhalation powder delivered by Novel Dry Powder Inhaler
Médicament: Fluticasone furoate 50mcg
Inhalation powder delivered by Novel Dry Powder Inhaler
Comparateur placebo: Placebo
Inhalation powder delivered by Novel Dry Powder Inhaler
Médicament: Placebo
Inhalation powder delivered by Novel Dry Powder Inhaler

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period
Délai: Baseline and Week 12
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 12 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.
Baseline and Week 12

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 12-week Treatment Period
Délai: From Baseline up to Week 12
The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
From Baseline up to Week 12
Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period
Délai: From Baseline up to Week 12
PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
From Baseline up to Week 12
Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period
Délai: From Baseline up to Week 12
PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
From Baseline up to Week 12
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 12-week Treatment Period
Délai: From Baseline up to Week 12
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
From Baseline up to Week 12
Number of Participants Who Withdrew Due to a Lack of Efficacy During the 12-week Treatment Period
Délai: From the first dose of the study medication until Week 12/Early Withdrawal
The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.
From the first dose of the study medication until Week 12/Early Withdrawal

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

GlaxoSmithKline

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2011

Achèvement primaire (Réel)

1 juin 2012

Achèvement de l'étude (Réel)

1 août 2012

Dates d'inscription aux études

Première soumission

15 septembre 2011

Première soumission répondant aux critères de contrôle qualité

15 septembre 2011

Première publication (Estimation)

19 septembre 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

11 janvier 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 novembre 2016

Dernière vérification

1 novembre 2016

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 115283

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Oui

Description du régime IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Données/documents d'étude

  1. Plan d'analyse statistique
    Identifiant des informations: 115283
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  2. Spécification du jeu de données
    Identifiant des informations: 115283
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protocole d'étude
    Identifiant des informations: 115283
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  4. Rapport d'étude clinique
    Identifiant des informations: 115283
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formulaire de consentement éclairé
    Identifiant des informations: 115283
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  6. Ensemble de données de participant individuel
    Identifiant des informations: 115283
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  7. Formulaire de rapport de cas annoté
    Identifiant des informations: 115283
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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